Access to Clinical Trial Data - The "Irreversible Process"

25 February 2013

Sarah Faircliffe

The issue of ensuring transparency of the activities of regulators is nothing new, with public bodies being required to observe Freedom of Information legislation and transparency policies for some time now, both at EU and Member State level.  As far as medicines regulators are concerned, the particular topic of access to clinical trial data, filed in support of marketing authorisation applications, is currently being debated, following pressure from a number of sources to move towards greater transparency of clinical trial results.

The path so far has been far from smooth; as well as media interest in the issue of inaccessible data, the European Medicines Agency (EMA) has previously had to defend its position before the European Ombudsman, in the face of requests for access to trial data. An attempt by the EMA to refuse access to clinical study reports and trial protocols for two anti-obesity drugs was referred to the European Ombudsman, following a complaint from the Danish researchers who had requested access in order to carry out an independent analysis.

In mid-2010, the Ombudsman found that the EMA’s refusal to grant access on the grounds that disclosure would undermine the drug producers’ commercial interests was a case of “maladministration” and that the EMA should either disclose the material or produce convincing arguments as to why access could not be given, since disclosure would not in fact, in the Ombudsman’s view, undermine commercial interests. The EMA finally accepted this position and granted the access requested, and has since widened its transparency policy considerably.

In a new attempt to move the trial data access debate forward, the EMA organised a workshop on 22 November 2012, where a wide selection of interested parties presented their views. The EMA made clear that there is no longer any debate about whether access to trial data submitted as part of an application dossier will be granted once the assessment procedure has been completed, as there is already a commitment to provide full access and the “process is irreversible”; the only remaining questions relate to how access will be provided.

Speakers at the meeting included the Assistant European Data Protection Supervisor, a representative of the European Ombudsman, academics, industry and patient representatives and those speaking on behalf of the media. The various issues up for discussion included the possibility for industry to introduce bias into their data analysis if there is no potential for public scrutiny, the need to protect personal data/ patient confidentiality, the protection of IPRs and R&D investment, the format in which data should be made available and the need to guard against poor analysis. In the case of products where the outcome of the marketing authorisation assessment is a withdrawal of the application or a negative opinion, the industry position presented was that release of data in such cases could damage the future of the product if resubmitted at a later data with additional data, or submitted outside the EU.

In general, there was industry support for a case-by-case review of data access, with a number of factors being taken into account including the nature of the product, the data presented, its place in its lifecycle and the method of release; analyses should also be defined and reviewed, allowing interested parties to comment. The speaker representing the European Rare Diseases Organisation, speaking on behalf of patients, also emphasised that the risks surrounding data privacy issues can vary depending on the disease area, citing very rare (or ultra-orphan) diseases as an example of where it can be easy to trace data back to an individual patient. This can only be addressed by reviewing case-by-case what data can be released, he claimed.

The final outcome was a call for volunteers to form five advisory groups, which have now started work. They are to deliver firm proposals by the end of April 2013, covering the following areas: protecting patient confidentiality; clinical trial data formats; rules of engagement; good analysis practice; legal aspects. The EMA has then promised to issue a policy on proactive publication of clinical trial data in January 2014.

Since the workshop was held, individual companies are adopting new positions on releasing clinical information. For example, GSK has very recently declared that it will disclose much more background information about its trials in the form of clinical study reports for all medicines on its clinical trial website, once approved for sale or dropped from development and after the results have been published, as well as details of trials for all approved medicines dating back to its formation in 2000.  This move is made in the context of the “AllTrials” campaign calling for all trials to be registered and all results reported. 

The Association of the British Pharmaceutical Industry (ABPI) Code of Practice has, since 2012, included a clause that all clinical trial results should be published within a year of obtaining a marketing authorisation, and new clinical trials should be publicly registered within 21 days of first patient enrolment. However, the ABPI maintains that it is a matter for individual companies whether or not they sign up to the AllTrials scheme.

Meanwhile, the general issue of open access to research findings, particularly where research is publicly funded, continues to be debated at national level. In the UK, the Government is pursuing an open access policy, and other influential bodies such as the British Medical Journal, Medical Research Council and The Wellcome Trust (the largest private funder of medical research in the UK) have become involved in support of open access. The proposal made by the Government Minister for Universities in January is that publicly funded research should be immediately available for anyone to read for free by 2014, although many high profile individuals and bodies have expressed reservations about this. Most clinical trials are funded by the pharmaceutical industry rather than the taxpayer, but the development is significant nevertheless.

There has also been a notable recent shift towards more collaborative pharmaceutical research, involving individual or groups of companies and academic / publicly funded institutions pooling resources and sharing data and research outcomes, all of which points to the clinical trial and research landscape having a very different sort of future than what has gone before, particularly when it comes to transparency and collaboration.


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